The federal Food & Drug Administration granted pre-market approval to Abiomed Inc.‘s AB Portable driver, clearing the way for the Danvers-based cardiac device maker to bring the portable support console component to market.
The device is designed to power Abiomed‘s AB5000 circulatory support system, which provides temporary support for one or both sides of the heart when the heart has failed but could recover, according to the company’s website.
Abiomed said it received investigational device exemption approval from the FDA in May 2008 for a clinical trial of the AB Portable driver, the so-called Voyager I outpatient study. Eight hospitals have received institutional review board approval to enroll in the trial.